If approved by the European Commission for this indication, solriamfetol will be the only licensed therapy in Europe for the treatment of excessive daytime sleepiness in adults living with obstructive sleep apnea

DUBLIN, November 15, 2019 – Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending the marketing authorisation of solriamfetol to improve wakefulness and reduce excessive daytime sleepiness (EDS) in adults with narcolepsy (with or without cataplexy) or obstructive sleep apnea (OSA) whose EDS has not been satisfactorily treated by primary OSA therapy, such as continuous positive airway pressure (CPAP).1

“Today’s positive CHMP opinion is an important milestone for people living with EDS associated with narcolepsy or OSA, which has been shown to negatively impact the lives of people living with these conditions,” said Robert Iannone, M.D., M.S.C.E., executive vice president, research and development of Jazz Pharmaceuticals. “This milestone brings us one step closer to potentially providing a new treatment option for people living with these sleep disorders in Europe.”

The Marketing Authorisation Application (MAA) for solriamfetol is based on data from four randomised placebo-controlled studies included in the Treatment of Obstructive sleep apnea and Narcolepsy Excessive Sleepiness (TONES) clinical trial program. Data from the studies in the TONES program demonstrated the superiority of solriamfetol relative to placebo.2-5

The CHMP recommended that once daily solriamfetol be approved with doses of 75 mg and 150 mg for people with narcolepsy and doses of 37.5 mg, 75 mg and 150 mg for people with OSA.1

“Excessive daytime sleepiness due to narcolepsy or OSA may have negative impacts on a person’s ability to function at work or at home, and in OSA patients EDS can still occur despite the compliant use of CPAP treatment for upper airway obstruction,” said Professor Jean-Louis Pépin, M.D., Ph.D., Director of INSERM unit 1042 and head of the sleep and physiology department at the University Hospital in Grenoble, France. “I am hopeful this positive CHMP opinion leads to this novel treatment option becoming available for people living with EDS as a result of narcolepsy or OSA.”

Solriamfetol is a dual-acting dopamine and norepinephrine reuptake inhibitor (DNRI) shown to improve wakefulness in adults living with excessive daytime sleepiness due to narcolepsy or obstructive sleep apnea (OSA). 2-7 Solriamfetol, marketed as Sunosi® in the U.S., received U.S. Food and Drug Administration (FDA) approval on March 20, 2019 to improve wakefulness in adult patients with EDS associated with narcolepsy or OSA and was designated a Schedule IV medicine by the U.S. Drug Enforcement Agency (DEA) on June 17, 2019.8,9 In 2014, Jazz Pharmaceuticals acquired a license to develop and commercialize solriamfetol from Aerial Biopharma LLC. Jazz Pharmaceuticals has worldwide development, manufacturing, and commercialization rights to solriamfetol, excluding certain jurisdictions in Asia. SK Biopharmaceuticals Co., Ltd., the discoverer of the compound, maintains rights in 12 Asian markets, including Korea, China, and Japan. Sunosi has orphan drug designation for narcolepsy in the United States.

About Obstructive Sleep Apnea and Excessive Daytime Sleepiness

Obstructive sleep apnea (OSA), commonly referred to as sleep apnea, is a highly prevalent disease affecting approximately 44% of Europeans.10Excessive daytime sleepiness (EDS), a major symptom of OSA, is characterized by the inability to stay awake and alert during the day resulting in unplanned lapses into sleep or drowsiness.11,12 Positive Airway Pressure (PAP) therapy, with its most common form being Continuous Positive Airway Pressure (CPAP), has been shown to be an effective therapy for sleep apnea that frequently results in improvement in EDS in many patients;13,14 however, not all patients tolerate CPAP therapy and among those who tolerate CPAP, usage is highly variable.15,16,17 EDS may persist in people with OSA despite using CPAP.18,19

About Narcolepsy

Narcolepsy is a chronic, debilitating neurological disorder characterized by excessive daytime sleepiness (EDS), and the inability to regulate sleep-wake cycles normally.20 Narcolepsy is a rare disease with an estimated prevalence of 0.02% in European populations.21 Studies have shown it may take 10 years or more for people with narcolepsy to receive a diagnosis, and it is estimated that more than 50% of patients with narcolepsy have not been diagnosed.22,23,24 There are five primary symptoms of narcolepsy, including EDS, cataplexy, sleep-related hallucinations, sleep paralysis and sleep disruption.11 While all patients with narcolepsy experience EDS, they may not experience all five symptoms.11

About Jazz Pharmaceuticals

Jazz Pharmaceuticals plc (Nasdaq: JAZZ), a global biopharmaceutical company, is dedicated to developing life-changing medicines for people with limited or no options. As a leader in sleep medicine and with a growing hematology/oncology portfolio, Jazz has a diverse portfolio of products and product candidates in development, and is focused on transforming biopharmaceutical discoveries into novel medicines. Jazz Pharmaceuticals markets Sunosi® (solriamfetol), Xyrem® (sodium oxybate) oral solution, Defitelio® (defibrotide sodium), Erwinaze® (asparaginase Erwinia chrysanthemi) and Vyxeos® (daunorubicin and cytarabine) liposome for injection in the U.S. and markets Defitelio® (defibrotide), Erwinase® and Vyxeos® liposomal 44 mg/100 mg powder for concentrate for solution for infusion in countries outside the U.S. For country-specific product information, please visit https://www.jazzpharmaceuticals.com/medicines. For more information, please visit www.jazzpharmaceuticals.com and follow us on Twitter at @JazzPharma.

Malhotra et al. A Long-Term Safety and Maintenance of Efficacy Study of Solriamfetol (JZP-110) in the Treatment of Excessive Sleepiness in Subjects With Narcolepsy or Obstructive Sleep Apnea. Poster 331 presentetd at SLEEP 2018, the 32nd Annual Meeting of the Associated Professional Sleep Societies June 2–6, 2018.

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